Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality

NCT06880783 | Recruiting DMC

• 1 other identifier: Diabetes and Sleep Quality
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate if there is a significant effect of manual diaphragmatic release technique on exercise capacity, sleep quality, chest expansion, ADL, fatigue and quality of life in older adults with type II diabetes.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• 6-minute walk test

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

  up to 6 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete

  up to 6 weeks

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Participants will receive manual diaphragm release technique combined with deep breathing exercises

Other: manual diaphragm release technique; Other: deep breathing exercises

Control group

ACTIVE COMPARATOR

Participants will receive deep breathing exercises

Other: deep breathing exercises

Interventions

manual diaphragm release technique OTHER

The participant should be supine with relaxed limbs, and the therapist should position themselves at the head, making manual contact with the pisiform, hypothenar region, and fingers. The therapist should gently pull the contact towards the head, deepen it during exhalation, and gradually increase the depth.

Study Group

deep breathing exercises OTHER

Participants in a crook laying position are instructed to inhale through the nose, lift the abdomen, and let out through the mouth, breathing six breaths per minute for 30 minutes.

Control group; Study Group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of Diabetes Type II for more than one year.
• They will be well controlled with HbA1c≤7.
• Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m².
• Patients will follow up on the training program and instructions. They will be medically stable.

You may not qualify if:

• Chest diseases.
• Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.
• History of Myocardial infarction and/or cardiothoracic surgery
• Unstable medical status.
• Cognitive disability hindering responding to the questionnaires.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni suef hospital

Banī Suwayf, 62511, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mohammed Yo Elhamrawy, Ph.D

CONTACT

+201282805567; dr_melhamrawy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical therapy

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)